South Africa has suspended the rollout of the Johnson & Johnson (J&J) COVID-19 vaccine as a precautionary measure.

This comes after the United States Food and Drug Administration (FDA) and Centres for Disease Control and Prevention (CDC) paused the rollout of the vaccine following reports of a rare clotting condition in six people out of 6.8 million doses administered. 

Announcing the decision, Health Minister, Dr Zweli Mkhize, said there have been no reports of clots formed since 289 787 healthcare workers have been vaccinated under the Sisonke Study. 

“Having said that, after this advisory came to my attention I held urgent consultations with our scientists, who have advised that we cannot take the decision made by the FDA lightly,” the Minister said on Tuesday evening.

Based on their advice, Mkhize said government has decided to voluntarily suspend the rollout until the link between the clots and the J&J vaccine is adequately interrogated.

Meanwhile, he said the South African Health Products Regulatory Authority (SAHPRA) will collate information from J&J, the FDA and other regulatory bodies to make a thorough assessment. 

“I humbly call for calm and patience as we ensure that we continue to be properly guided by science in ensuring the safety of our people as we roll out the vaccine campaign.”

Mkhize believes that the matter will be cleared in a few days and that it will not have any significant impact on the entire rollout programme.

“Given the preliminary literature on hand, our scientists are confident that the FDA’s decision is on a precautionary basis and we expect that this will not result in the complete withdrawal of the Johnson & Johnson vaccine from the vaccination armament.”

Pfizer vaccines

The Minister also announced that the country has successfully negotiated for another 10 million doses from Pfizer, of which two million of these are expected to be delivered in May.

“This, therefore, means we have secured 30 million doses of the Pfizer vaccine for this financial year.”

The Minister has expressed confidence that in an unlikely event that the J&J rollout is completely halted, the country would still be able to proceed with phase two of the vaccination programme.

“We are confident that the rollout of Johnson & Johnson will resume and so, with 30 million doses of Johnson & Johnson and 30 million doses of Pfizer secured, we now have enough doses to exceed the 40 million we were targeting this year.”

According to the Minister, this is in line with government’s commitment to inoculate as many people as possible this year.

“In the ideal scenario, we would vaccinate every single adult found in South Africa.”

He said government makes commitments and works to the best of its ability to honour them, however, science should be respected at all times.

“This sometimes means a disruption in our plans. Although we are operating in a dynamic and ever-changing environment, the government is constantly seeking to secure vaccines that will protect us from the 501Y.V2 variant.”

Risk

SAHPRA Chairperson, Professor Helen Rees, said the regulator will also weigh in on the benefit of vaccines to individuals and society versus the risk that could be “tiny”. 

“That’s the discussion that needs to be had and we’ll be very honest with the public because if the risk is tiny and the risk of death and disease from COVID-19 is huge, particularly for certain populations of people, that’s when we make those kinds of decisions,” she said.

However, the Professor said the SAHPRA will have a full discussion once they understood whether there is a causal link with this rare side effect or not.